Committee wants tighter regulations for specialty labs

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Massachusetts pharmacists who specially mix injectable and other sterile medications would be required to take continuing education classes, and their pharmacies would have to provide patients with the number of a staffed hotline to report problems under legislation approved Tuesday by the Joint Committee on Public Health and aimed at preventing a repeat of the deadly fungal meningitis outbreak blamed on a Framingham speciality pharmacy.

The legislation also would require the state Department of Public Health to develop and maintain a website that allows the public to search state records of enforcement actions against problem pharmacies and to search records about adverse reactions reported by patients who have taken drugs from Massachusetts-licensed pharmacies.

“This is about transparency, access, and enforcement,” said Representative Jeffrey Sánchez, a Jamaica Plain Democrat and House chairman of the committee.

“I feel excited that this is something that could really make a difference,” Sánchez said, “but at the same time, it comes at the unfortunate cost of loss of life and suffering.”

Sixty-one
people died and more than 740
in 20 states were sickened last year by tainted steroids produced at New England Compounding Center in Framingham. The company, which has since closed, was one of about 40 specialty pharmacies in Massachusetts, known as compounders, that custom make drugs for individual patients who need doses or preparations that are not available off the shelf. Some compounders, including New England Compounding, specialize in mixing sterile products, which can include injections, intravenous solutions, and eye drops.

Sánchez’s plan requires stronger oversight of compounding pharmacies by the state Pharmacy Board.

It mandates random, surprise inspections of the facilities and of the sterile drugs they produce.

After the meningitis outbreak, Governor Deval Patrick directed state regulators to conduct surprise inspections. Sánchez said he wants to ensure that oversight “survives after this current administration.”

Sánchez’s bill would also maintain a majority of pharmacists on the 11-member state board that regulates the industry, an requirement at odds with a plan introduced by the Patrick administration earlier this year. Patrick’s proposal tipped that balance, placing pharmacists in the minority, just four out of 11, because he felt that fewer pharmacists would mean stronger, more independent oversight.

The Patrick administration declined comment Tuesday on the board’s composition, but issued a statement saying it was reviewing Sánchez’s legislation and thanked lawmakers for “including many of the same principles as the governor’s bill.”

Two trade associations representing Massachusetts pharmacists issued a joint statement saying they were pleased with the bill, including the provision that retained pharmacists as a majority on the board.

“The bill’s proposed changes to the Board of Registration in Pharmacy will ensure independence for the board, while not diminishing the critical professional input that only a pharmacist can offer,” they said.

Sánchez’s bill establishes an unpaid committee of industry experts to advise the pharmacy board, a provision applauded by Sarah Sellers, a former US Food and Drug Administration official who advocates more stringent regulation of compounding pharmacies.

Sellers said the panel can help educate board members, who may not be aware of the many public health risks posed by higher-volume compounding undertaken by many pharmacies.

But Sellers said having a majority of pharmacists as board members creates a conflict of interest.

“It would be analogous to having employees of [pharmaceutical manufacturer] Pfizer being part of FDA’s Office of Compliance, making decisions on when to take action against a pharmaceutical company,” she said.

The legislation also establishes fines for pharmacies and pharmacists found in violation of the new rules.

It proposes a penalty of not more than $25,000 against pharmacies for an infraction and a fine of not more than $1,000 per day against a pharmacy for each additional day a facility is found to be not complying with a corrective order issued by the state Pharmacy Board.

Pharmacists could face fines of up to $1,000 for not complying with the proposed rules requiring 20 hours of continuing education during each 2-year license renewal cycle, with at least five of those hours devoted to sterile compounding.

Sánchez’s committee conducted public hearings last fall about the state’s pharmacy industry and then further scrutinized the issue for eight months, he said, meeting with federal and state regulators and pharmacists to craft the proposed legislation.

Sánchez said he learned from the hearings that communication between and among state and federal regulators overseeing the pharmacy industry was a “big problem,” so the proposed legislation aims to add transparency by requiring state specialty pharmacies to report adverse drug events to the FDA’s MedWatch Program, now required only of big drug manufacturers.

“We don’t know of any other state doing this,” Sánchez said.

Money to enforce provisions of the committee’s proposed legislation will come from penalties assessed on pharmacies that break the rules and from licensing fees.

The bill now moves on to review by the Joint Committee on Ways and Means.